CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 222 enrolled
Drug / intervention
JNJ-61393215 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04080752
NCT04080752Phase 2Completed

Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants

Janssen Research & Development, LLC·interventional·Posted Sep 6, 2019·Updated Apr 29, 2025

In Brief

A Phase 2 clinical trial evaluating JNJ-61393215 and Placebo for Major Depressive Disorder With Anxious Distress. Completed, enrolled 222 participants across 35 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (\>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMoldova, Russia, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 6, 2019
Enrollment StartSep 17, 2019
Primary CompletionSep 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.8 years ago

Interventions

JNJ-61393215drug

JNJ-61393215 will be administrated orally.

Placebodrug

Matching placebo will be administered orally.